A Pilot Study to Evaluate the Pharmacokinetics of Omega-3 Between Rosuvastatin and Omega-3 Coadministration and HCP1007

Phase 1CompletedNCT01929070

Hanmi Pharmaceutical Company Limited12 enrolled

Overview

The purpose of this study is to evaluate the pharmacokinetics of omega-3 between rosuvastatin and omega-3 coadministration and HCP1007 in healthy male volunteers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

HCP1007DRUG

Omarco and CrestorDRUG

Eligibility

Sex: MALEMin age: 20 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Adult male aged 20 to 55 years * A body mass index between 19 and 27 kg/m2 Exclusion Criteria: * History of hepatobiliary, renal, gastrointestinal, respiratory, musculoskeletal, endocrinal, hemato-oncologic or cardiovascular disease * SBP \< 90 or ≥ 150 mmHg, DBP \< 60 or ≥90 mmHg * Use of herbal medicine within 30 days, prescriptive medicine within 14 days, or over-the-counter drug within 7 days * Heavy alcohol consumption (140 g/day)

Locations (1)

Samsung medical center

Seoul, South Korea

Outcomes

Primary Outcomes

Cmax_adj of DHA and EPA

Time frame: -24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h (on the high-fat diet only)

AUClast_adj of DHA and EPA

Time frame: -24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h (on the high-fat diet only)